Latest Biopharmaceuticals News

Race Oncology has secured key ethics approvals to launch its Phase 1 RC220 trial at two major Hong Kong hospitals, marking a strategic expansion beyond Australia to accelerate patient recruitment and explore cardioprotective benefits.

Telix Pharmaceuticals has achieved a key milestone with its next-generation prostate cancer imaging agent, Gozellix, receiving a permanent HCPCS code from U.S. Medicare. This paves the way for broader reimbursement and market adoption starting October 2025.

Argent BioPharma has begun supplying its EU-GMP cannabinoid API for drug-resistant epilepsy treatment at University Medical Centre Ljubljana, marking a key clinical and regulatory milestone in Europe.

Dimerix Limited has received a significant milestone payment from its Japanese partner FUSO Pharmaceutical, marking progress in the Phase 3 clinical trial of DMX-200 for kidney disease. This payment underscores the growing momentum behind Dimerix’s global licensing strategy.

NeuroScientific Biopharmaceuticals has completed its acquisition of StemSmart stem cell technology, setting the stage for a focused clinical push in treating fistulising Crohn’s disease. The company also refreshed its board and raised $7.5 million to support this next phase.

Radiopharm Theranostics has inked a clinical supply agreement with Cyclotek to support its Phase 1 trial of RAD 402, a novel radiotherapeutic targeting prostate cancer, set to commence in Australia in late 2025.

Tryptamine Therapeutics has secured ethics approval to begin a pioneering clinical trial of TRP-8803, an IV-infused psilocin treatment, targeting adult patients with Binge Eating Disorder. The trial aims to evaluate safety and efficacy, with initial results expected by the end of 2025.

NeuroScientific Biopharmaceuticals reveals compelling clinical evidence supporting its StemSmart MSC therapy for severe steroid-refractory graft versus host disease, advancing its strategic acquisition plans.

Race Oncology has successfully dosed the first patient with its RC220 and doxorubicin combination in a Phase 1 trial for advanced solid tumours, reporting no dose-limiting side effects. This milestone marks a key step in evaluating the safety and potential cardioprotective benefits of the novel therapy.

CLINUVEL’s Phase II pilot study reveals afamelanotide monotherapy does not trigger repigmentation in vitiligo patients, underscoring the necessity of adjunct NB-UVB phototherapy.

Dimerix has reached a key milestone by dosing 200 adult patients in its Phase 3 ACTION3 trial for FSGS, progressing steadily toward full recruitment expected in late 2025.

Telix Pharmaceuticals showcased its global theranostic radiopharmaceutical portfolio, highlighting FDA approvals, clinical progress, and a robust commercial expansion plan at its 2025 Investor Day.